A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

Trial Information

A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

OBJECTIVES:

I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune
response and is associated with acceptable toxicity in patients with malignant metastatic
melanoma.

II. Determine all clinical toxicities associated with this regimen in this patient
population.

III. Determine the safety of this regimen in this patient population. IV. Assess evidence of
host antimelanoma immune reactivity following this regimen.

V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response
in this patient population receiving this regimen.

VII. Evaluate quality of life of these patients during this regimen.

OUTLINE: This is a dose escalation study.

Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8).
Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease
progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.

Quality of life is assessed before treatment, every 4 weeks, and at end of treatment.
Patients are followed every 3 months.

- Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min

- No congestive heart failure

- No serious cardiac arrhythmias

- No recent prior myocardial infarction

- No clinical coronary artery disease

- No chronic obstructive pulmonary disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No seizure disorders

- No underlying immunosuppressive disorder

- No autoimmune disease HIV negative

- No skin diseases

- No open wounds

- No eczema or other contraindications to vaccinia virus administration

- Patients must be able to avoid high risk individuals (e.g., immunosuppressed
patients, children under 3 years, pregnant women, patients with active or a history
of eczema, or patients with other skin conditions) for 7-10 days following treatment

- No significant allergy or hypersensitivity to eggs

- No active or chronic infections

- No concurrent medical illness

- No other significant medical disease which would increase risk to patient

- No other prior malignancy within the past 5 years except stage I carcinoma of the
cervix or basal cell carcinoma

Completion Date:

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